Incident Report
Subform I: General Information
1. Report Type.
Update the report
Incident Report Number: 2008-4621
2. Registrant Information.
Registrant Reference Number: 080111553
Registrant Name (Full Legal Name no abbreviations): Wellmark International
Address: 100 Stone Road West, Suite 111
City: Guelph
Prov / State: Ontario
Country: Canada
Postal Code: N1G5L3
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
04-OCT-08
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
Unknown
Product Description
7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.
Active(s)
PMRA Registration No. 26496
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Spot On Flea Control For Cats And Kittens
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
Units: mL
10. Site pesticide was applied to (select all that apply).
Site: Animal / Usage sur un animal domestique
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
On October 1 or 2, 2008, the owner applied the product to her cat as a form of treatment.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Longhair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
9
7. Weight (provide a range if necessary )
10
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Drooling
- Nervous and Muscular Systems
- Nervous and Muscular Systems
- Symptom - Seizure
- Symptom - Ataxia
- Cardiovascular System
- Symptom - Other
- Specify - severe myocardial fibrosis
- Respiratory System
- Symptom - Pulmonary edema
- Liver
- Symptom - Other
- Specify - hepatic congestion
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
Unknown
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Died
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On October 4, the owner gave the cat a bath with tea tree oil shampoo for cats. On the same day, the owner called the Animal Product Safety Service (APSS). The APSS veterinarian stated that with the use of this product, dermal hypersensitivity reactions can be seen. In addition, hypersalivation, vomiting, lethargy, ataxia, tremors, agitation, and mild, self-limiting anorexia may occur if the product was ingested. The APSS veterinarian recommended that the owner take the body to the veterinarian, have the attending veterinarian call for information, consider necropsy and hair testing, and to call the APSS back with any questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The APSS veterinarian doubted that the substance was related to causing the clinical situation. On October 14, a staff member from the veterinary clinic called the APSS to state that the body was submitted for a necropsy. Test results are pending.